Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572363
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven

Brief Summary:

In patients with one anatomical or functional ventricular chamber, which encompasses a spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in view of an ultimate Fontan operation has become the procedure of choice. Especially in the earlier era, perioperative mortality was the leading cause of death. However, many patients have a long and high-quality life, continuously improved by a better understanding of Fontan hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of eventual failure of the Fontan circulation remains a major concern. More specifically, evaluation of the pulmonary circulation becomes particularly important as the failing Fontan circulation has become a common indication for cardiac transplantation. Although essential, especially in the preoperative setting, a comprehensive evaluation of the pulmonary circulation remains difficult in this patient population

Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the development of pulmonary vascular lesions after the Fontan operation and that - together the absence of a subpulmonary ventricle for pressure generation - this increasing afterload will result in systemic ventricular underfilling and will eventually lead to a failing Fontan circulation.

Condition or disease Intervention/treatment
Congenital Heart Disease Drug: Sildenafil

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fontan Patients: Comprehensive Evaluation of the Pulmonary Circulation to Identify Pulmonary Vascular Disease and Its Influence on Ventricular Hemodynamics.
Study Start Date : April 2012
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sildenafil
All patients will be given Sildenafil 50 mg with evaluation of pulmonary vascular resistance and systemic ventricular function at rest and during exercise after 30 minutes.
Drug: Sildenafil
50 mg once
Other Names:
  • Viagra
  • Revatio

Primary Outcome Measures :
  1. Systemic ventricular stroke volume during exercise [ Time Frame: 30 minutes after administration of sildenafil ]
    Systemic ventricular stroke volume during exercise as evaluated using bicycle stress magnetic resonance imaging.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥ 14 years of age
  • Written informed consent
  • Fontan pathology

Exclusion Criteria:

  • Inability to performe exercise
  • Contra-indication for MR evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572363

University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Werner Budts, MD, PhD University Hospitals Leuven

Responsible Party: Alexander Van De Bruaene, Dr, Universitaire Ziekenhuizen Leuven Identifier: NCT01572363     History of Changes
Other Study ID Numbers: ML6721
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven:
Cardiac magnetic resonance imaging

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents